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NDC 72932-0003-00 Zonsen Povidone-Iodine Prep Pad 100 mg/mL Details

Zonsen Povidone-Iodine Prep Pad 100 mg/mL

Zonsen Povidone-Iodine Prep Pad is a TOPICAL SWAB in the HUMAN OTC DRUG category. It is labeled and distributed by Wuhan Zonsen Medical Products Co., Ltd.. The primary component is POVIDONE-IODINE.

Product Information

NDC	72932-0003
Product ID	72932-003_89569a9d-d57a-f72d-e053-2a95a90aa9b9
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Zonsen Povidone-Iodine Prep Pad
Proprietary Name Suffix	n/a
Non-Proprietary Name	POVIDONE-IODINE
Product Type	HUMAN OTC DRUG
Dosage Form	SWAB
Route	TOPICAL
Active Ingredient Strength	100
Active Ingredient Units	mg/mL
Substance Name	POVIDONE-IODINE
Labeler Name	Wuhan Zonsen Medical Products Co., Ltd.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2024-12-31

Package

Package Images

NDC 72932-0003-00 (72932000300)

Pricing Information	N/A
NDC Package Code	72932-003-00
Billing NDC	72932000300
Package	1 PACKET in 1 POUCH (72932-003-00) / .45 mL in 1 PACKET
Marketing Start Date	2019-04-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c325c062-9e74-4059-9e62-1621c39019ee Details

Drug Facts

Active Ingredients

Povidone-Iodine 10% w/w (1% available iodine)

Purpose

Antiseptic

Use

Healthcare antiseptic for preparation of the skin prior to surgery.
First aid antiseptic to help prevent infection in minor cuts, scrapes and burns.

Warnings

For external use only.

Do not use

in the eyes.
longer than 1 week unless directed by a doctor.
on individuals who are allergic or sensitive to iodine.
or apply over large areas of the body.

Stop use and ask a doctor if

If irritation and redness develop.
condition persist for more than 72 hours.
In case of deep or puncture wounds, animal bites or serious burns, consult a doctor.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Clean the affected area.
For preparation of the skin prior to surgery: apply product to the operative site prior to surgery
For first aid antiseptic: apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.

Inactive Ingredients:

Sodium hydroxide, water

Other information

Protect from freezing
Avoid excessive heat.

Package Labeling:

INGREDIENTS AND APPEARANCE

ZONSEN POVIDONE-IODINE PREP PAD

povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72932-003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	100 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72932-003-00	1 in 1 POUCH	04/01/2019
1		0.45 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	04/01/2019

Labeler - Wuhan Zonsen Medical Products Co., Ltd. (554474517)

Name	Address	ID/FEI	Business Operations
Establishment
Wuhan Zonsen Medical Products Co., Ltd.		554474517	manufacture(72932-003)

Revised: 5/2019

Document Id: 89569a9d-d57a-f72d-e053-2a95a90aa9b9

Set id: c325c062-9e74-4059-9e62-1621c39019ee

Version: 4

Effective Time: 20190520